NCT04795453

Brief Summary

Necrotizing enterocolitis(NEC) is one of the most serious disease in the newborn infants, and two and more grades of NEC usually lead to surgery, even death. But, it is difficult to predict when to operate the surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 14, 2022

Status Verified

October 1, 2022

Enrollment Period

3.8 years

First QC Date

March 5, 2021

Last Update Submit

October 13, 2022

Conditions

Necrotizing EnterocolitisNeonateSurgery

Outcome Measures

Primary Outcomes (7)

  • sensitivity of the score system for predicting the need of surgery

    sensitivity of the score system for predicting the need of surgery is assessed

    before surgery

  • specificity of the score system for predicting the need of surgery

    specificity of the score system for predicting the need of surgery is assessed

    before surgery

  • accuracy of the score system for predicting the need of surgery

    accuracy of the score system for predicting the need of surgery is assessed

    before surgery

  • positive likelihood ratio of the score system for predicting the need of surgery

    positive likelihood ratio of the score system for predicting the need of surgery is assessed

    before surgery

  • negative likelihood ratio of the score system for predicting the need of surgery

    negative likelihood ratio of the score system for predicting the need of surgery is assessed

    before surgery

  • positive predictive value of the score system for predicting the need of surgery

    positive predictive value of the score system for predicting the need of surgery is assessed

    before surgery

  • negative predictive value of the score system for predicting the need of surgery

    negative predictive value of the score system for predicting the need of surgery is assessed

    before surgery

Study Arms (2)

assessment of usual method to predict the need for surgery

two and more grades of NEC is assessed using the usual method to predict the need for surgery

Other: score system to predict the need for surgeryOther: usual method to predict the need for surgery

assessment of score system to predict the need for surgery

two and more grades of NEC is assessed using the score system to predict the need for surgery

Other: score system to predict the need for surgeryOther: usual method to predict the need for surgery

Interventions

score system to predict the need for surgeryOTHER

two and more grades of NEC is assessed using the score system to predict the need for surgery

assessment of score system to predict the need for surgeryassessment of usual method to predict the need for surgery
usual method to predict the need for surgeryOTHER

two and more grades of NEC is assessed using the usual method to predict the need for surgery

assessment of score system to predict the need for surgeryassessment of usual method to predict the need for surgery

Eligibility Criteria

Age1 Hour - 44 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

two and more of NEC is diagnosed in newborn infants during hospitalization

You may qualify if:

  • two and more of NEC is diagnosed in the newborn infants
  • on the time of diagnosis for NEC both the surgery and non-surgery are reasonable according the surgeon's suggestions

You may not qualify if:

  • pneumoperitoneum
  • refusing to take part in the study according to parents' decision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chen（陈）

Chongqing, Chongqing Municipality, 400014, China

RECRUITING

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Central Study Contacts

Chen Long, MD, PhD

CONTACT

+8613883559467neuroclong@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

March 5, 2021

First Posted

March 12, 2021

Study Start

March 1, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

October 14, 2022

Record last verified: 2022-10

Locations

CN(1)